Clearance Summary
VYGON DOUBLE LUMEN UMBILICAL CATHETER received FDA 510(k) clearance under submission number K981630, sponsored by Schiff & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1998-10-01.
- Submission: K981630
- Applicant / Sponsor: Schiff & Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 1998-10-01
Classification & Regulation
This clearance is catalogued under FDA product code FOS and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.